Cleared Traditional

TNT TROPONIN T

K942632 · Streck Laboratories, Inc. · Immunology
Sep 1994
Decision
98d
Days
Class 1
Risk

About This 510(k) Submission

K942632 is an FDA 510(k) clearance for the TNT TROPONIN T, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on September 9, 1994, 98 days after receiving the submission on June 3, 1994. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K942632 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 1994
Decision Date September 09, 1994
Days to Decision 98 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

Similar Devices — JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 492
Beta-CrossLaps CalCheck 5
K170678 · Roche Diagnostics · Apr 2017
Elecsys CYFRA 21-1 CalCheck 5
K162173 · Roche Diagnostics · Jan 2017
Multichem A1c
K162514 · Technopath Manufacturing · Oct 2016
Audit MicroControls Linearity DROP LQ Blood Glucose
K161874 · Aalto Scientific, Ltd. · Aug 2016
LIAISON EBV IgM Serum Control Set
K161522 · DiaSorin, Inc. · Jun 2016
LIAISON CMV IgM Serum Control Set
K161526 · DiaSorin, Inc. · Jun 2016